Quarterly Cashflow Report

Jan 30th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2018

Shareholder Update January 2019

Jan 17th, 2019

In this issue: 

>> FDA requests further data for VivaGel^® BV approval in the US

>> Launch of VivaGel^® BV in multiple territories

>> VivaGel^® BV licensed to ITF Pharma in the US

>> VivaGel^® condom approved in Japan

>> Clinical trials for internal DEP^® products progressing well

>> Patent published for AstraZeneca-DEP^® drugs: DEP^® Bcl2/xL inhibitors show compelling efficacy & synergy in combination

>> DEP^® docetaxel & DEP^® cabazitaxel outperformed both gemcitabine & Abraxane^®

>> SPL7013 eye drops for viral conjunctivitis

>> Partnering activities 

>> Macquarie initiates coverage of Starpharma

>> Outlook

 Download: Shareholder Update January 2019 (pdf file, 557kb)

VivaGel® condom receives final regulatory approval in Japan

Jan 2nd, 2019

Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel^® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel^® condom.

US FDA requests further data for VivaGel® BV approval

Dec 27th, 2018

Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel^® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).

US VivaGel® BV licensed for A$142M milestones, plus royalties

Dec 20th, 2018

Melbourne, Australia: Starpharma and ITF Pharma today announced they have signed a licence for the sales and marketing rights to VivaGel^® BV in the United States. Starpharma will be eligible to receive up to US$101M (A$142M) in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.

US patent granted for SPL7013 eye drops for conjunctivitis

Dec 12th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US Patent and Trademark Office has granted a patent for SPL7013 ophthalmic drops for viral conjunctivitis. The patent has been granted with broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent term is to 2033.

AGM - Chairman address and CEO presentation

Nov 29th, 2018

Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 3.00pm today.

DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model

Nov 16th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP^® docetaxel and DEP^® cabazitaxel products, which are both currently in the clinic, showed significant efficacy and safety benefits over gemcitabine (Gemzar^®) alone, Abraxane^® (Nab-paclitaxel) alone and in combination, in a human pancreatic cancer model. These impressive efficacy results were despite the fact that these standard pancreatic cancer treatments, gemcitabine and/or Abraxane^® showed limited activity in this model.

Quarterly Cashflow Report

Oct 26th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018

Starpharma Investor Presentation for Citi Conference

Oct 17th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) will today participate in Citi's 10th Annual Australian and New Zealand Investment Conference in Sydney.

DEP® irinotecan outperforms in pancreatic cancer model

Sep 5th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP^® irinotecan development candidate showed significant efficacy and safety benefits over standard irinotecan in combination with 5-FU in a mouse xenograft model of human pancreatic cancer (Figure 1 and 2). The human pancreatic tumour model used in this study virtually did not respond to the traditional irinotecan regimen (irinotecan + 5-FU), whereas complete tumour regression and 100% survival was achieved using Starpharma’s DEP^® irinotecan.

AstraZeneca’s DEP Bcl2/xL inhibitors show compelling efficacy and synergy in combination

Aug 31st, 2018

Melbourne, Australia; Starpharma today announced AstraZeneca’s first patent application on DEP^® Bcl2/xL conjugates has been published by the World Intellectual Property Organisation. These DEP^® Bcl2/xL conjugates combine Starpharma’s innovative DEP^® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitor for treating various cancers, including leukemias.

The published patent application shows compelling efficacy data on DEP^® Bcl2/xL conjugates, both alone and in combination with other leading current anti-cancer treatments, in various preclinical human tumour models.

Annual report and full year financial results

Aug 21st, 2018

Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2018.

Quarterly Cashflow Report

Jul 17th, 2018

Melbourne, Australia; Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2018.

VivaGel® BV NDA advances to next stage of FDA review

Jul 9th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US FDA has completed its filing review of the VivaGel^® BV New Drug Application (NDA), with no issues identified, and confirmed its progress to the next stage.

Starpharma licenses VivaGel® BV to Mundipharma for Europe

Jun 27th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a licence agreement for the sales and marketing rights to VivaGel®BV for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America. This deal builds on the VivaGel® BV licence signed with Mundipharma in May 2018 for Asia, the Middle East, Africa and parts of Latin America. 

Mundipharma licenses Starpharma’s VivaGel® BV

May 3rd, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a multi-region licence for the sales and marketing rights to VivaGel^® BV in Asia (including China, Japan and Korea), the Middle East, Africa and the majority of Latin America.

Quarterly Cashflow Report

Apr 30th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2018.

Starpharma completes US New Drug Application for VivaGel® BV

Apr 30th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its rolling new drug application (NDA) for VivaGel^® BV including two indications, for the treatment of bacterial vaginosis (BV) and prevention of BV, has been completed, and the final module of the NDA will be submitted to the US Food and Drug Administration (FDA) on Monday 30 April 2018 (US time).

Starpharma to present at OTCQX Virtual Investor Conference

Apr 11th, 2018

Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that as part of its OTCQX investor communications, a pre-recorded presentation by Chief Executive Officer Dr Jackie Fairley will be broadcast at VirtualInvestorConferences.com on Thursday 12 April 2018 at 10:30am (US ET time).

Starpharma on CommSec’s The Executive Series

Mar 14th, 2018

Starpharma CEO Dr Jackie Fairley on Channel 9’s The Today Show for International Women’s Day

Mar 8th, 2018

Starpharma Interim Report and Half-Year Financial Results

Feb 26th, 2018

Starpharma today released its interim report and financial results for the half-year ended 31 December 2017.

Starpharma receives $3.7M R&D tax incentive refund

Feb 22nd, 2018

Starpharma today announced that it has received a $3.7M R&D tax incentive refund associated with FY17 expenditures. The refund relates to eligible R&D expenditure across Starpharma’s portfolio, including VivaGel^® and DEP^® programs.

Shareholder Update February 2018

Feb 19th, 2018

In this issue: 

>> New sites open for the DEP^® docetaxel phase 2 trial

>> DEP^® cabazitaxel phase 1 / 2 trial commences

>> VivaGel^® BV NDA submission lodged under Fast Track program

>> VivaGel^® BV approved by TGA

>> DEP^® irinotecan progressing towards the clinic

>> AstraZeneca-Starpharma collaboration

>> Extensive global licensing negotiations for VivaGel^® BV

>> Positive market research findings for VivaGel^® BV 

>> Q2 Cashflow Report at 31 December 2017

>> OTCQX market recognition

>> Starpharma News & Events

>> Outlook

 Download: Shareholder Update February 2018 (pdf file, 1.5mb)

Starpharma to commence DEP® cabazitaxel phase 1/2 trial

Jan 31st, 2018

Starpharma today announced that it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP^® cabazitaxel. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP^® cabazitaxel, to define a recommended phase 2 dose (RP2D), and then to determine anti-tumour efficacy of the product in select tumour types.

VivaGel® BV treatment clinical submission under rolling submission

Dec 21st, 2017

Melbourne, Australia; 21 December 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has completed the VivaGel^® BV treatment clinical section of the NDA clinical module, which will be submitted to the FDA under Starpharma’s rolling submission on Friday 22 December 2017 (US time). 

NDA submission for Starpharma’s VivaGel® BV

Nov 21st, 2017

Starpharma receives TGA marketing approval for VivaGel® BV

Oct 25th, 2017

VivaGel® BV granted marketing approval in Australia

Oct 25th, 2017

Starpharma today announced it has received Australian marketing approval from the Therapeutic Goods Administration (TGA) for VivaGel^® BV, which is intended for treatment of bacterial vaginosis (BV).

Morgans Under the Microscope Interview featuring Dr Jackie Fairley

Oct 23rd, 2017

Morgans Under the Microscope series featured Starpharma's CEO, Dr Jackie Fairley, discussing a number of key milestones that are approaching and the licensing arrangements entered into with AstraZeneca. 

Listen to the podcast (external link). 

Shareholder Update October 2017

Oct 18th, 2017

In this issue: 

>> DEP^® docetaxel achieves positive phase 1 results and commences phase 2

 >> AZ presents first DEP^® candidate AZD0466 – a Bcl2/xL inhibitor

>>  Successful VivaGel^® BV phase 3 results

>> Update on other internal DEP^® candidates

>> Grant awarded to Starpharma-Monash

>> Starpharma and Peter Mac Cancer Centre awarded grant

>> FY17 Financial results; >$60M cash at 30 June

>> Annual Report and Annual General Meeting

>> Starpharma News & Events

Download: Shareholder Update October 2017 (pdf file, 1.3mb)

Starpharma and Peter Mac Cancer Centre awarded DEP® Grant

Oct 9th, 2017

Starpharma and Peter MacCallum Cancer Centre have been awarded a further Federal Government Innovation Connections grant to support innovative research within Starpharma’s DEP^® oncology program

AstraZeneca presents first DEP® candidate as Bcl2/xL inhibitor

Sep 28th, 2017

 Starpharma advises that AstraZeneca has this week presented its first DEP^® candidate utilising Starpharma’s DEP^® delivery platform,  AZD0466, at the 3rd AstraZeneca-MedImmune-CRUK Cambridge Centre Symposium 2017 in Cambridge, UK.

DEP® docetaxel positive phase 1 results; phase 2 commences

Sep 22nd, 2017

Starpharma today announced that its phase 1 trial for DEP^® docetaxel has achieved the key objective of determining a Recommended Phase 2 Dose (RP2D), with no reports of protocol-defined dose limiting toxicities (DLTs). The trial has now been adapted to transition seamlessly into phase 2, with ethics and regulatory approvals already granted, and recruitment and patient screening activities underway for this next phase.

Starpharma annual report and full year financial results

Aug 28th, 2017

Melbourne, Australia; 28 August 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2017.

Starpharma and Monash awarded STEM+ Business Fellowships

Aug 9th, 2017

Starpharma today announced that Starpharma and Monash Institute of Pharmaceutical Sciences (MIPS) have been awarded $300,000 in grant funding from the SIEF STEM⁺ Business Fellowship Program to engage two post-doctoral Research Fellows. 

Successful VivaGel® Phase 3 results and NDA planned for rBV

Aug 7th, 2017

Starpharma today announced that its two phase 3 trials of VivaGel^® BV for prevention of recurrent bacterial vaginosis (rBV) achieved their primary objective demonstrating statistically significant superiority compared to placebo in preventing rBV based on topline data.

Shareholder Update July 2017

Jul 4th, 2017

In this issue: 

>> Starpharma sells Agrochemicals business to Agrium for $35M cash

>> DEP^®  irinotecan outperforms irinotecan in multiple cancer models

>> DEP^®  docetaxel, DEP^®  cabazitaxel and scale-up facilities

>> AstraZeneca pays US$2M DEP^®  milestone to Starpharma

>> VivaGel^®  BV phase 3 results timing and commercialisation

>> VivaGel^®  condom launched in Canada

>> Sale of Ansell's Sexual Wellness division

>> Starpharma News & Events

Download: Shareholder Update July 2017 (pdf file, 710kb)

Sale of Agrochemicals Business Investor Presentation

Jun 14th, 2017

Melbourne, Australia; 14 June 2017: Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), will be holding an investor conference call today at 11am (AEST) to discuss the sale of its Agrochemicals business to Agrium Inc., for $35 million. A presentation featuring further information on the transaction is available.

Starpharma sells Agrochemicals business to Agrium for $35M

Jun 14th, 2017

Melbourne, Australia; 14 June 2017: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced that it has completed a transaction to sell its agrochemicals and Priostar^® business (Starpharma Agrochemicals) to Agrium, Inc., (Agrium) (NYSE: AGU, TSE: AGU) for A$35 million in cash consideration. The Starpharma Agrochemical business willl be operated by Agrium’s wholly-owned subsidiary, Loveland Products, Inc.

DEP® irinotecan outperforms irinotecan in multiple cancer models

Jun 6th, 2017

Melbourne, Australia; Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its proprietary DEP^® irinotecan has demonstrated significantly better anti‑tumour activity and increased survival compared with irinotecan in a variety of human colon cancer models. 

AstraZeneca DEP® candidate advance triggers milestone to Starpharma

Apr 20th, 2017

 Starpharma announced the achievement of a key preclinical milestone for its DEP^® drug delivery technology in combination with a proprietary oncology molecule from AstraZeneca.

Ansell launches VivaGel® condom in Canada

Apr 12th, 2017

Starpharma is pleased to announce the VivaGel^® condom has been launched in Canada by Ansell under the LifeStyles^® Dual Protect^™ brand. 

VivaGel® BV phase 3 trials for prevention of BV completed

Mar 30th, 2017

Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced completion of its international, multicentre, phase 3 clinical studies evaluating VivaGel^® BV for the prevention of recurrent bacterial vaginosis (rBV). Starpharma expects topline results of the trials to be available in the second quarter of 2017.

VivaGel® BV granted QIDP and Fast Track designation by US FDA

Jan 12th, 2017

Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel^® BV by the US Food and Drug Administration (FDA).

Shareholder Update April 2016

Apr 13th, 2016

In this issue:

> Message from the CEO

> Adama licenses Priostar^® for 2,4-D

> DEP^TM cabazitaxel shows superior performance

> Starpharma's Targeted DEP^TM conjugates - compelling results in an area of high interest

> AstraZeneca selects second DEP^TM candidate

> Starpharma long standing collaborator ranked 4th in the world

> Starpharma signs licence with Aspen for commercialisation of VivaGel^® BV in Australia and New Zealand

> MOU for VivaGel^® condom in China

> Half-year financial results

> Bio-Europe^® conference

Download: Shareholder Update April 2016 (pdf file, 1MB)

Adama Licenses Starpharma's Priostar for Novel 2,4-D

Mar 17th, 2016

Starpharma and Adama today announced the licensing by Adama of Starpharma's Priostar^® dendrimer technology for the development and commercialization of an enhanced, proprietary 2,4-D herbicide for the US market. 2,4-D is one of the top three herbicides sold world-wide, with global sales in 2014 estimated by Phillips McDougall to be around US$680 million. The US market in 2014 was worth approximately US$115 million, and has been projected by the US Department of Agriculture to grow by more than 70% by 2020.  

Starpharma licences VivaGel® BV to Aspen for ANZ

Mar 4th, 2016

Starpharma today announced the signing of a License and Supply Agreement with Aspen Pharmacare Australia Pty Ltd for the sales and marketing of VivaGel^® BV in Australia and New Zealand (ANZ).

Targeted DEP™ shows sustained superior performance

Feb 2nd, 2016

Starpharma today announced the final results of the preclinical study of its HER2-targeted DEP™ conjugate, which achieved complete tumour regression at the last study time point of 120 days post dosing.